ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration


Jose Mora is Keynote Speaker at Compliance key Inc.He is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.........

Overview

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2015 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records. The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003. Next, the speaker will provide an overview of the updated standard.

Why should you attend this webinar?

The changes to this standard will have profound implications to how Quality Management Systems (QMSs) interact internally and between different supply chain agents.
It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.
Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization's quality processes.
If you are already constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use.
This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Areas Covered in the Session:

ISO 13485 2016 versus ISO 13485 2003

Overview of ISO 13485 2015:

Who can Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:



Webinar Id: LSHCJM004

Training Options:

Duration: 90 mins

 Recorded: [Six month unlimited access]

 $237(Single Attendee)  $599(Unlimited Attendee)

Refund Policy
Upcoming Webinar of Jose Mora
Past Webinar of Jose Mora
Upcoming Webinar :Life Sciences and Healthcare
Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity
By: Edwin Waldbusser
When: 10/24/2017 | 10:00 AM PT |01:00 PM ET
Price: $179
Course Description - How to Write and Manage a Change Control System
By: Danielle DeLucy
When: 10/24/2017 | 10:00 AM PT |01:00 PM ET
Price: $179

More Webinar

Past Webinar : Life Sciences and Healthcare
    
Copyright © 2017 Compliance Key . All Rights Reserved. Back to Top